Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP in Four Different Countries

Cholangiopancreatography, Endoscopic Retrograde Clinical Trial

— PREVENT  

Official title:

Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an Endoscopic Retrograde Cholangiopancreatography in Four Different Countries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05303662
• Other study ID #: NL79136.078
• Status: Recruiting
• Start date: January 31, 2022
• Est. completion date: October 15, 2024

Study information

• Verified date: September 2023
• Source: Erasmus Medical Center
• Contact: K. van der Ploeg, MD
• Phone: +31650032327
• Email: k.ploeg[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The duodenoscopes currently used for Endoscopic Retrograde Cholangio - and Pancreaticography (ERCP) examinations are reusable and are therefore washed and disinfected after each use. Despite this, these endoscopes sometimes remain contaminated with bacteria. Several reports of outbreaks linked to contaminated duodenoscopes have been published worldwide. Recently, the Food and Drug Administration (FDA) advised manufacturers and health care professionals to transition away from fixed endcap duodenoscopes and instead focus more on the use of duodenoscopes with disposable components or fully disposable duodenoscopes. Single-use endoscopes have been developed, but they are not yet widely used, partly because of the extra costs that these endoscopes add to the examination. A possible interim solution, is to only use these disposable endoscopes in patients who carry multi-resistant bacteria in order to prevent the spread of these bacteria. For this, it is important to know how many people who undergo an ERCP carry multi-resistant bacteria. The primary objective of this study is to measure the prevalence of multi-resistant bacteria in patients undergoing ERCP in four different countries: India, the Netherlands, Italy and the United States. In the Netherlands, some secondary outcomes will be investigated with regard to the prevalence of duodenoscope contamination, the risk of bacterial transmission via a contaminated duodenoscope and the presence of multi-resistant bacteria in the duodenum.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1372
• Est. completion date: October 15, 2024
• Est. primary completion date: September 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject is planned to undergo an ERCP procedure, either through an outpatient department or an inpatient department
• The subject is capable to understand the information required to give informed consent

Exclusion Criteria:

• In case the inclusion criteria were not met

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde

Intervention

Diagnostic Test:
• Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs
Pooled throat/nose sample and a rectal sample is taken prior to the ERCP
• MDRO-testing duodenal aspirate
Duodenal aspirate is collected from the duodenum, diluted and undiluted. Then cultured for presence of MDRO's
• Microbiome through rectal swab
An rectal swab is collected for microbiome purposes
• Microbiome testing duodenal aspirate
Duodenal aspirate is collected from the duodenum, diluted and undiluted for microbiome analysis

Locations

Country	Name	City	State
India	AIG hospitals	Hyderabad	Telangana
Italy	Humanitas research hospital	Milano	Lombardy
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Marco J. Bruno	Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  India,  Italy,  Netherlands, 

References & Publications (1)

Rauwers AW, Voor In 't Holt AF, Buijs JG, de Groot W, Hansen BE, Bruno MJ, Vos MC. High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study. Gut. 2018 Sep;67(9):1637-1645. doi: 10.1136/gutjnl-2017-315082. Epub 2018 Apr 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of multidrug resistant micro-organism carriage in patients undergoing an ERCP in four different countries	Prevalence (as a percentage) of Methicillin-resistant Staphylococcus aureus (MRSA) in nasal or throat swabs, along with rectal carriage rates of Extended Spectrum Beta-Lactamase (ESBL), Vancomycin-resistant Enterococci (VRE), Carbapenem-resistant Enterobacterales (CRE), Carbapenemase-Producing Pseudomonas aeruginosa (CPP), and resistant Acinetobacter among ERCP patients in India, the Netherlands, Italy, and the United States.	1 week
Secondary	Prevalence of multidrug resistant micro-organism carriage in the duodenum of patients undergoing ERCP compared to the rectum	Prevalence (as a percentage) of duodenal carriage of MRSA, ESBL, VRE, CRE, CPP, and resistant Acinetobacter among ERCP patients in both India and the Netherlands.	1 week
Secondary	Differences of rectal microbiome between ERCP patients carrying MDRO compared to patients without MDRO	Sequencing data analysis, such as 16S rRNA gene sequencing, will be used to assess the overall composition of the rectal microbiome. This will involve the identification of various bacterial taxa present in the samples and determining their relative proportions. The results will provide information on the broader microbial community composition.; These results will be compared between ERCP patients carrying MDRO and those without MDRO to investigate differences in both specific bacterial species' abundance and overall microbiome composition.	1 week
Secondary	Prevalence of duodenoscope-associated infections and colonizations	Comparison of isolates form duodenoscope cultures with isolates from clinical cultures from patients treated with a contaminated duodenoscope in order to detect transmission.	6 months
Secondary	Differences of duodenal microbiome between ERCP patients carrying MDRO compared to patients without MDRO	Sequencing data analysis, such as 16S rRNA gene sequencing, will be used to assess the overall composition of the duodenal microbiome. This will involve the identification of various bacterial taxa present in the samples and determining their relative proportions. The results will provide information on the broader microbial community composition.; These results will be compared between ERCP patients carrying MDRO and those without MDRO to investigate differences in both specific bacterial species' abundance and overall microbiome composition.	1 week